Bayer, Onyx seek approval for gastrointestinal tumor drug

Bayer submits application to FDA for regorafenib

WAYNE, N.J. — Bayer HealthCare and Onyx Pharmaceuticals are seeking approval for a new drug to treat tumors of the gut, the companies said.

Bayer and Onyx announced the submission to the Food and Drug Administration of an application seeking approval for regorafenib in patients with gastrointestinal stromal tumors, or GIST. Bayer developed the drug and formed a partnership with Onyx in 2011, whereby Onyx will receive a royalty on future global net sales of the drug in cancer-related indications. Both companies will promote the drug in the United States.

"The submission of regorafenib for the treatment of GIST marks an important milestone for Bayer, bringing us one step closer to potentially addressing a significant medical need for patients with this rare but aggressive disease," Bayer HealthCare Pharmaceuticals VP and head of U.S. medical affairs Pamela Cyrus said. "With the development of regorafenib and other oncology compounds, we remain committed to discovering and advancing cancer therapies for patients who are in need of new treatment options."

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